BEUDAMED
    FDA Recall Open, Classified

    CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 00811400410 00811400420 00811400423 00811400426 00811400430 00811400500 00811400510 00811400530 00811401218 00811401318 00811404000 00811405000

    Recall: Z-2450-2024 · Initiated July 2, 2024

    Recall

    Recall Number
    Z-2450-2024
    Event Number
    94923
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    JDI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 2, 2024
    Posted
    July 30, 2024
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 00811400410 00811400420 00811400423 00811400426 00811400430 00811400500 00811400510 00811400530 00811401218 00811401318 00811404000 00811405000

    Reason

    Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.

    Action

    On July 2, 2024, the firm notified customers through Urgent Medical Device Correction letters. Customers were informed of the increased risk of postoperative periprosthetic femoral fracture (PFF). The firm will be updating the IFU to reflect the risk of PFF, with anticipated release by the end of August 2024. In addition, the firm will begin phasing out the device with a target of December 2024 to stop sales. The latest IFU can be viewed electronically at labeling.zimmerbiomet.com and entering the part number. If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday, or email [email protected]. *** UPDATED 9/18/24: Follow-up communication was distributed to impacted US surgeons on September 18, 2024. This updated letter reflected FDA's Medical Device Safety Communication issued on September 17, 2024, which provided additional recommendations on the use of the affected product during the phase out period, including that surgeons should consider using an alternative prosthesis where possible. The FDA Safety Communication can be found here: https://www.fda.gov/medical-devices/safety-communications/zimmer-biomet-cpt-hip-system-femoral-stem-and-increased-risk-thigh-bone-fracture-fda-safety?utm_medium=email&utm_source=govdelivery. The updated letter also includes a plain language communication that may be provided to patients. The firm stated all US surgeons will be transitioned to alternative brands and the CPT Hip System Femoral Stem will be exited in the US by the end of October 2024.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    5,500 (US); 242,000 (OUS)